> The only measured exploratory covariate with a significant interaction with treatment was lifetime history of SSRI use, which was associated with improved efficacy of MDMA-AT (P = 0.02; Supplementary Table 5). Covariates significantly impacting the main effect were sex assigned at birth and baseline Beck Depression Inventory (BDI)-II score; female sex assigned at birth and baseline BDI-II score ≥23 were both associated with improved outcomes irrespective of treatment assignment (P < 0.05).
This is an interesting outcome, particularly the SSRI usage
> Eight participants (MDMA-AT, n = 7; placebo with therapy, n = 1) experienced cardiac TEAEs, which included palpitations (MDMA-AT, n = 5 (9.4%); placebo with therapy, n = 1 (2.0%)) and tachycardia (MDMA-AT, n = 2 (3.8%)); all were mild.
Seems a bit concerning, but I have little to measure this against.
> superiority of MDMA-AT over SSRIs cannot be assumed without a direct comparison
I feel as though this should be done. Even though the results are promising they come with a significant safety risk for the participants who are essentially at the mercy of the administrator and could be easily subject to abuse.
That being said, for people with severe PTSD this is surely a godsend. Maybe we can mitigate the safety issue other ways.